oSIST prEN ISO 20031:2022

Radiological protection - Monitoring and dosimetry for internal exposures due to wound contamination with radionuclides (ISO 20031:2020)

This document specifies the requirements for personal contamination monitoring and dose assessment following wounds involving radioactive materials. It includes requirements for the direct monitoring at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and systemic doses following the wound event.
It does not address:
—     details of monitoring and assessment methods for specific radionuclides;
—     monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds, including hot particles;
—     therapeutic protocols. However, the responsible entity needs to address the requirements for decontamination and decorporation treatments if appropriate.

Strahlenschutz - Überwachung und Dosimetrie für innere Expositionen aufgrund von Wundkontaminationen mit Radionukliden (ISO 20031:2020)

Radioprotection - Surveillance et dosimétrie en cas d'exposition interne due à la contamination d'une plaie par radionucléides (ISO 20031:2020)

Le présent document spécifie les exigences relatives à la surveillance de la contamination individuelle et l'évaluation de la dose à la suite de plaies impliquant des matériaux radioactifs. Il inclut les exigences relatives à la surveillance directe du site de la plaie, la surveillance du transfert des radionucléides dans l'organisme et l'évaluation des doses locales et systémiques après un événement de type plaie.
Elle ne traite pas des aspects suivants:
—          détails des méthodes de surveillance et d'évaluation pour des radionucléides spécifiques;
—          surveillance et évaluation de la dose pour les matériaux en contact avec la peau intacte ou des plaies préexistantes, y compris les particules contaminées;
—          protocoles thérapeutiques. Toutefois, il est nécessaire que l'entité responsable réponde aux exigences en matière de traitements de décontamination et de décorporation s'il y a lieu.

Radiološka zaščita - Nadzorovanje in dozimetrija notranje izpostavljenosti zaradi kontaminacije rane z radionuklidi (ISO 20031:2020)

General Information

• Status: Not Published
• Public Enquiry End Date: 19-Jun-2022
• ICS: 13.280 - Radiation protection
• Technical Committee: I13 - Imaginarni 13
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 06-Apr-2022
• Due Date: 24-Aug-2022
• Ref Project: prEN ISO 20031 - Radiological protection - Monitoring and dosimetry for internal exposures due to wound contamination with radionuclides (ISO 20031:2020)

Standards Content (sample)

SLOVENSKI STANDARD
oSIST prEN ISO 20031:2022
01-maj-2022

Radiološka zaščita - Nadzorovanje in dozimetrija notranje izpostavljenosti zaradi

kontaminacije rane z radionuklidi (ISO 20031:2020)

Radiological protection - Monitoring and dosimetry for internal exposures due to wound

contamination with radionuclides (ISO 20031:2020)
Strahlenschutz - Überwachung und Dosimetrie für innere Expositionen aufgrund von
Wundkontaminationen mit Radionukliden (ISO 20031:2020)

Radioprotection - Surveillance et dosimétrie en cas d'exposition interne due à la

contamination d'une plaie par radionucléides (ISO 20031:2020)
Ta slovenski standard je istoveten z: prEN ISO 20031
ICS:
13.280 Varstvo pred sevanjem Radiation protection
oSIST prEN ISO 20031:2022 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 20031:2022
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oSIST prEN ISO 20031:2022
DRAFT
EUROPEAN STANDARD
prEN ISO 20031
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2022
ICS 13.280
English Version
Radiological protection - Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides (ISO 20031:2020)

Radioprotection - Surveillance et dosimétrie en cas Strahlenschutz - Überwachung und Dosimetrie für

d'exposition interne due à la contamination d'une plaie innere Expositionen aufgrund von

par radionucléides (ISO 20031:2020) Wundkontaminationen mit Radionukliden (ISO
20031:2020)

This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee

CEN/TC 430.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations

which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other

language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC

Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without

notice and shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN ISO 20031:2022 E

worldwide for CEN national Members.
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oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Annex 1 A-Deviation for EN ISO 20031 ................................................................................................................. 4

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oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
European foreword

The text of ISO 20031:2020 has been prepared by Technical Committee ISO/TC 85 "Nuclear energy,

nuclear technologies, and radiological protection” of the International Organization for Standardization

(ISO) and has been taken over as prEN ISO 20031:2022 by Technical Committee CEN/TC 430 “Nuclear

energy, nuclear technologies, and radiological protection” the secretariat of which is held by AFNOR.

This document is currently submitted to the CEN Enquiry.
Endorsement notice

The text of ISO 20031:2020 has been approved by CEN as prEN ISO 20031:2022 without any

modification.
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oSIST prEN ISO 20031:2022
prEN ISO 20031:2022 (E)
Annex 1
A-Deviation for EN ISO 20031
Clause Deviation
General Germany
Incorporation monitoring in Germany is legally regulated by the German
Guidelines on physical radiation protection control for determination of
the body dose part 2: Determination of the body dose of internal
exposition (incorporation monitoring) of January 12, 2007.
Regarding the measurements and the quality control described in this
standard shall comply with the guideline on physical radiation protection
control for determination of the body dose part 2: Determination of the
body dose of internal exposition (incorporation monitoring) of January 12,
2007
9.5 Germany
Measurement uncertainties as described in this clause are legally not
taken into account in Germany.
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oSIST prEN ISO 20031:2022
INTERNATIONAL ISO
STANDARD 20031
First edition
2020-02
Radiological protection — Monitoring
and dosimetry for internal exposures
due to wound contamination with
radionuclides
Radioprotection — Surveillance et dosimétrie en cas d'exposition
interne due à la contamination d'une plaie par radionucléides
Reference number
ISO 20031:2020(E)
ISO 2020
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
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Phone: [phone]
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Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Symbols and abbreviated terms ........................................................................................................................................................... 5

4.1 Symbols ......................................................................................................................................................................................................... 5

4.2 Abbreviated terms ............................................................................................................................................................................... 5

5 Purpose and need for special monitoring programmes for internal exposures due

to wound contamination with radionuclides ......................................................................................................................... 5

6 General aspects of wound contamination .................................................................................................................................. 6

6.1 Introduction .............................................................................................................................................................................................. 6

6.2 Category of wound contaminants ........................................................................................................................................... 6

6.3 Types of wounds and their specific retention of radionuclides.................................................................... 7

7 Monitoring programmes to assess contamination via a wound ......................................................................... 7

7.1 Introduction .............................................................................................................................................................................................. 7

7.2 Main steps for the monitoring and dosimetry for internal exposures due to wound

contamination with radionuclides ......................................................................................................................................... 7

7.3 Collection of information to characterize the contaminated wound ....................................................... 8

7.3.1 General...................................................................................................................................................................................... 8

7.3.2 Information concerning the type of wound .................. ............................................................................ 9

7.3.3 Information concerning the radioactive contaminant .................................................................... 9

7.4 In vivo wound measurements .................................................................................................................................................... 9

7.5 Systemic activity monitoring ...................................................................................................................................................10

8 Performance criteria for radiobioassay measurements ..........................................................................................11

9 Procedure for local and systemic dose assessment ......................................................................................................11

9.1 Local (wound site) dose assessment ................................................................................................................................11

9.2 Systemic dose assessment .........................................................................................................................................................11

9.3 Impact of medical intervention on dose assessment ..........................................................................................13

9.3.1 Local chelation therapy and/or the excision of contaminated tissue from

the wound ...........................................................................................................................................................................13

9.3.2 Decorporation therapy ............................................................................................................................................13

9.4 Software tools for bioassay data interpretation ......................................................................................................13

9.5 Uncertainties .........................................................................................................................................................................................14

9.5.1 General...................................................................................................................................................................................14

9.5.2 Uncertainties on local dose assessment ...................................................................................................14

9.5.3 Uncertainties on internal dose assessment ...........................................................................................14

9.6 Quality assurance...............................................................................................................................................................................14

10 Recording ..................................................................................................................................................................................................................15

10.1 Recording in vivo measurement results.........................................................................................................................15

10.2 Recording in vitro radiobioassay and treatment waste results .................................................................15

11 Documentation of the dose assessment ....................................................................................................................................16

12 Reporting ...................................................................................................................................................................................................................16

Annex A (informative) Schematic representation of NCRP wound model, default
parameters for retention equations and default transfer rates for the wound
model for the various categories of radionuclides in wounds (adapted from NCRP
[3]

report 156 (2007) ) ....................................................................................................................................................................................17

Annex B (informative) Types of wounds and their specific retention of radionuclides ..............................20

© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)

Annex C (informative) Example of a summary sheet that should follow the contaminated

worker during his initial care ..............................................................................................................................................................23

Annex D (informative) Overview of typical methods used for in vitro bioassay measurements .......24

−1 −1
Annex E (informative) Equivalent dose rate in a contaminated wound (mSv·h ·kBq )
−1 −1 2
and equivalent dose rate received by the skin (mSv·h ·kBq ·cm ) for selected

radionuclides ........................................................................................................................................................................................................25

Annex F (informative) Committed effective dose coefficients for intake of selected

radionuclides via a contaminated wound for all wound model categories (adapted
[11]

from Toohey RE et al., 2014 ) .........................................................................................................................................................27

[14]

Annex G (informative) The IDEAS Guidelines provide guidelines for the estimation of

committed doses from incorporation monitoring data in case of wound .............................................30

Bibliography .............................................................................................................................................................................................................................31

iv © ISO 2020 – All rights reserved
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following

URL: www .iso .org/ iso/ foreword .html.

This document was prepared by Technical Committee ISO/TC 85, Nuclear energy, nuclear technologies,

and radiological protection, Subcommittee SC 2, Radiological protection.
© ISO 2020 – All rights reserved v
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
Introduction

In the course of their employment, radiation workers may be exposed to radioactive materials that

could be incorporated into the body. Intakes of radionuclides need to be monitored to determine that

any exposures are at expected levels. Internal doses resulting from intakes of radionuclides cannot be

measured directly. Estimating the dose requires decisions to be made about the monitoring techniques

and frequencies along with methodologies for dose assessment. The criteria governing the regimes of

such a monitoring programme or for the selection of methods and frequencies of monitoring usually

depends upon regulations, the purpose of the radiation protection programme, the probabilities of

potential radionuclide intakes, and the characteristics of the materials handled.

[1]

For these reasons, ISO standards for monitoring programmes (ISO 20553 ), laboratory requirements

[2]

(ISO 28218), and dose assessment (ISO 27048 ) have been developed and can be applied to many

workplaces where internal contamination may occur. Their application for internal exposures due to

wound contamination with radionuclides requires account to be taken of special aspects resulting from

the type of wound and the associated specific biokinetics of radionuclides at the origin of contamination.

This document offers guidance for the design of a special monitoring programme and for dose

assessment in the case of wound contamination with radionuclides. Recommendations of international

expert bodies and international experience with the practical application of these recommendations

in radiological protection programmes have been considered in the development of this document. Its

application facilitates the exchange of information between authorities, supervisory institutions and

employers.
vi © ISO 2020 – All rights reserved
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oSIST prEN ISO 20031:2022
INTERNATIONAL STANDARD ISO 20031:2020(E)
Radiological protection — Monitoring and dosimetry for
internal exposures due to wound contamination with
radionuclides
1 Scope

This document specifies the requirements for personal contamination monitoring and dose assessment

following wounds involving radioactive materials. It includes requirements for the direct monitoring

at the wound site, monitoring of uptake of radionuclides into the body and assessment of local and

systemic doses following the wound event.
It does not address:
— details of monitoring and assessment methods for specific radionuclides;

— monitoring and dose assessment for materials in contact with intact skin or pre-existing wounds,

including hot particles;

— therapeutic protocols. However, the responsible entity needs to address the requirements for

decontamination and decorporation treatments if appropriate.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results — Part 1: General

principles and definitions

ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method

for the determination of repeatability and reproducibility of a standard measurement method

ISO 5725-3, Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate

measures of the precision of a standard measurement method
ISO 28218, Radiation protection — Performance criteria for radiobioassay

ISO/IEC Guide 99, International vocabulary of metrology — Basic and general concepts and associated

terms (VIM)
3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO/IEC Guide 99, ISO 5725-1,

ISO 5725-2, ISO 5725-3 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
© ISO 2020 – All rights reserved 1
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.1
absorption

movement of material into blood regardless of mechanism, generally applied to the uptake (3.32) into

blood of soluble substances and material dissociated from particles
3.2
activity
number of spontaneous nuclear disintegrations per unit time

Note 1 to entry: The activity is stated in becquerels (Bq), i.e. the number of disintegrations per second.

3.3
biokinetic model

model describing the time course of absorption (3.1), distribution, metabolism and excretion of a

substance introduced into the body of an organism
3.4
clearance

net effect of the biological processes by which radionuclides are removed from the body or from a

tissue, organ or region of the body
3.5
contamination

activity (3.2) of radionuclides present on surfaces, or within solids, liquids or gases (including the

human body), where the presence of such radioactive material is unintended or undesirable

3.6
decision threshold

value of the estimator of the measurand which, when exceeded by the result of an actual measurement

using a given measurement procedure of a measurand quantifying a physical effect or quantity, it is

decided that the physical effect or quantity is present
Note 1 to entry: Otherwise, this effect is assumed to be absent.
3.7
decontamination

complete or partial removal of radioactive contamination (3.5) by a deliberate physical, chemical, or

biological process
3.8
decorporation

method aiming to accelerate the elimination from the body of an incorporated radionuclide

3.9
detection limit

smallest true value of the measurand which ensures a specified probability of being detectable by the

measurement procedure

Note 1 to entry: With the decision threshold, the detection limit is the smallest true value of the measurand for

which the probability of wrongly deciding that the true value of the measurand is zero is equal to a specified

value, β, when, in fact, the true value of the measurand is not zero. The probability of being detectable is

consequently (1 − β).

Note 2 to entry: The terms detection limit and decision threshold are used in an ambiguous way in different

standards (e.g. standards related to chemical analysis or quality assurance). If these terms are referred to one

has to state according to which standard they are used.
3.10
dose coefficient

committed tissue equivalent dose per unit acute intake h (τ) or committed effective dose per unit acute

intake e(τ), where τ is the time period in years over which the dose is calculated [e.g. e(50)]

2 © ISO 2020 – All rights reserved
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.11
effective dose
sum of weighted equivalent doses (3.13) in all tissues and organs of the body
3.12
committed effective dose

sum of the products of the committed organ or tissue equivalent doses and the appropriate tissue

weighting factors

Note 1 to entry: In the context of this document, the integration time is 50 years following any intake.

3.13
equivalent dose

product of the absorbed dose and the radiation weighting factor for the specific radiations at this point

3.14
local dose
equivalent dose (3.13) in a defined volume or area at the wound site
3.15
systemic dose
committed effective dose (3.12) excluding the local dose at the wound site
3.16
event

any unintended occurrence, including operating error, equipment failure or other mishap, the

consequences or potential consequences of which are not or suspected not to be negligible from the

point of view of protection or safety
3.17
internal exposure
exposure to radiation from a source inside the body
3.18
intake

act or process of taking radionuclides into the body by inhalation, ingestion, absorption (3.1)

through the skin or through wounds
3.19
monitoring

measurements made for the purpose of assessment or control of exposure to radioactive material and

the interpretation of the results of such measurements
3.20
incorporation monitoring

monitoring (3.19) of radionuclides incorporated into the bodies of individual workers by measurement

of the quantities of radioactive materials in the bodies of individual workers, or by measurement of

radioactive material excreted by individual workers
3.21
individual monitoring

monitoring (3.19) by means of equipment worn by individual workers, by measurement of the quantities

of radioactive materials in or on the bodies of individual workers, or by measurement of radioactive

material excreted by individual workers
3.22
special monitoring programme

monitoring programme performed to quantify significant exposures following actual or suspected

abnormal events (3.16)
© ISO 2020 – All rights reserved 3
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oSIST prEN ISO 20031:2022
ISO 20031:2020(E)
3.23
quality assurance

planned systematic actions necessary to provide adequate confidence that a process, measurement or

service satisfy given requirements for quality such as those specified in a licence

3.24
quality control

part of quality assurance (3.23) intended to verify that systems and components correspond to

predetermined requirements
3.25
radiobioassay

procedure used to determine the nature, activity (3.2), location or retention of radionuclides in the body

by direct (in vivo) measurement or by indirect (in vitro) analysis of material excreted or otherwise

removed from the body
3.26
in vitro radiobioassay measurement

analyses that include measurements of radioactivity present in biological samples taken from an

individual
3.27
in vivo radiobioassay measurement

measurement of radioactive material in the human body utilizing instrumentation that detects

radiation emitted from the radioactive material in the body

Note 1 to entry: Normally, the measurement devices are whole-body or partial-body (e.g., lung, thyroid) counters.

3.28
responsible entity
person, body or service that is in charge of the monitoring (3.19) and dosimetry
3.29
retention function

function describing the fraction of an intake present in a biological compartment (whole body, tissue,

organ or excreta) after a given time has elapsed since the intake occurred
3.30
time of measurement

time at which the biological sample (e.g. urine, faeces) is taken from the individual

concerned
3.31
time of measurement
time at which the in vivo measurement begins
3.32
uptake

translocation of material from deposition site [wound (3.33), lung, etc.] into blood and subsequently to

systemic organs and tissues
3.33
wound

injury to the body in which the skin or other tissue is broken, cut, pierced, torn, scraped, burned, etc.

4 © ISO 2020 – All rights reserved
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